Acute Myeloid LeukemiaPhase 1AMLNCT07551037
Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy
A Phase 1 study testing Active Immunotherapy, after 6 courses of routine consolidation chemotherapy and during 6 courses of routine consolidation chemotherapy in people with Acute Myeloid Leukemia and Personalized Active Immunotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Personalized Active Immunotherapy, Maintenance Therapy
- What is being tested?
- Active Immunotherapy, after 6 courses of routine consolidation chemotherapy and during 6 courses of routine consolidation chemotherapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy.
- Aged 18 to 70 years.
- Receiving a maintenance therapy regimen without hormonal agents.
- Leukocyte and lymphocyte counts have basically returned to the normal range.
- Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission.
- Patients who voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Patients who still require hormonal maintenance therapy after achieving remission.
- Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.
- Having participated in other clinical trials within 1 month prior to screening.
- Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.
- Having other uncontrolled diseases that the investigator deems unfit for enrollment.
- Patients with psychiatric disorders or those known/suspected to be unable to fully comply with the study protocol.
Show all 18Show fewer
- Pregnant or lactating women.
- HIV-infected individuals.
- Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant safety risk to the subject.
- Withdrawal Criteria：
- Judged by the investigator to be in the best interest of the subject.
- Disease progression or initiation of other anti-leukemia therapy.
- The subject requests to withdraw from the study for any reason at any time.
- Lost to follow-up.
- Death.
- Occurrence of severe chemotherapy-induced toxic reactions, or chemotherapy delay of more than 4 weeks due to adverse reactions.
- Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of > 10%; or QTc prolongation meeting the following criteria: ① QTc > 500 ms; ② QTc > 530 ms in patients with bundle branch block.
- Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and/or aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Meijuan Huang, MD, 13365910912, huangmj@fjmu.edu.cn
About this study
Official title: A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate <40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate <20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic/nephrotoxic maintenance regimen effective for preventing recurrence.
Tumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve "full antigen coverage" personalized active immunity.
This study has significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.
- Being tested
- Active Immunotherapy, after 6 courses of routine consolidation chemotherapy, during 6 courses of routine consolidation chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ImmunotherapyBiological
Personalized tumor vaccines are prepared from the patient's own acute myeloid leukemia (AML) cells and administered via intradermal injection to induce the body to generate a specific anti-leukemia immune response.
after 6 courses of routine consolidation chemotherapyOther
Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.
during 6 courses of routine consolidation chemotherapyOther
Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| 6 courses of routine consolidation chemotherapy | No intervention | 6 courses of routine consolidation chemotherapy |
| Active immunotherapy administered during 6 courses of routine consolidation chemotherapy | Experimental | Active immunotherapy administered during 6 courses of routine consolidation chemotherapy Receives: Biological: Active Immunotherapy; Other: during 6 courses of routine consolidation chemotherapy |
| Active immunotherapy administered after 6 courses of routine consolidation chemotherapy | Experimental | Active immunotherapy administered after 6 courses of routine consolidation chemotherapy Receives: Biological: Active Immunotherapy; Other: after 6 courses of routine consolidation chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
subjects survival after treatment are finished
Measured: 1-year
overall remission rate (ORR)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
Measured: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
Secondary outcomes (3)
Time to Response(TTR)
The time from initiation of the study treatment to the first documentation of CR or PR.
Measured: 1-2months(1-2 courses）
Duratin of Response(DOR)
The time from first documentation of CR to the first documented disease progression or death, whichever occurs first
Measured: 1-year
Progression-Free Survival(PFS)
The time interval from the start of the study treatment to the first documentation of disease progression or death from any cause,whichever occurs first
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuangMeiJuan, Fujian Medical University Union Hospital
- Investigators
- Meijuan Huang, Study director, Fujian Institute of Haematology, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551037
- Sponsor's protocol ID
- FJ Depart of Hematology 2
- Acronym
- AML
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT07551037
- Acronym / sponsor ID
- AML / FJ Depart of Hematology 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate <40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate <20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic/nephrotoxic maintenance regimen effective for preventing recurrence.
Tumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve "full antigen coverage" personalized active immunity.
This study has significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 courses of routine consolidation chemotherapy | No intervention | –6 courses of routine consolidation chemotherapy |
| Active immunotherapy administered during 6 courses of routine consolidation chemotherapy | Experimental | Biological: Active Immunotherapy, Other: during 6 courses of routine consolidation chemotherapyActive immunotherapy administered during 6 courses of routine consolidation chemotherapy |
| Active immunotherapy administered after 6 courses of routine consolidation chemotherapy | Experimental | Biological: Active Immunotherapy, Other: after 6 courses of routine consolidation chemotherapyActive immunotherapy administered after 6 courses of routine consolidation chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy.
- Aged 18 to 70 years.
- Receiving a maintenance therapy regimen without hormonal agents.
- Leukocyte and lymphocyte counts have basically returned to the normal range.
- Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission.
Key exclusion criteria (18 listed)
- Patients who still require hormonal maintenance therapy after achieving remission.
- Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.
- Having participated in other clinical trials within 1 month prior to screening.
- Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.
- Having other uncontrolled diseases that the investigator deems unfit for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ImmunotherapyPersonalized tumor vaccines are prepared from the patient's own acute myeloid leukemia (AML) cells and administered via intradermal injection to induce the body to generate a specific anti-leukemia immune response. | Biological | Active immunotherapy administered after 6 courses of routine consolidation chemotherapy, Active immunotherapy administered during 6 courses of routine consolidation chemotherapy |
| after 6 courses of routine consolidation chemotherapyInitiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase. | Other | Active immunotherapy administered after 6 courses of routine consolidation chemotherapy |
| during 6 courses of routine consolidation chemotherapyInitiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase. | Other | Active immunotherapy administered during 6 courses of routine consolidation chemotherapy |
Primary outcome
overall survival (OS)
Time frame: 1-year
subjects survival after treatment are finished
overall remission rate (ORR)
Time frame: At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)
subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)
3 secondary outcomes
Time to Response(TTR)
Time frame: 1-2months(1-2 courses）
Duratin of Response(DOR)
Time frame: 1-year
Progression-Free Survival(PFS)
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meijuan Huang study director
Fujian Institute of Haematology, Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active Immunotherapy, after 6 courses of routine consolidation chemotherapy and during 6 courses of routine consolidation chemotherapy in people with Acute Myeloid Leukemia and Personalized Active Immunotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meijuan Huang (13365910912, huangmj@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.